CAVUX Cervical Cage-B PD-31-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00852776006003), received between Oct 7, 2016 and Aug 11, 2017 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A PATIENT WHO RECEIVED POSTERIOR C4-C7 CERVICAL INTERVERTEBRAL FUSION ON (B)(6) 2016 HAD TO GO THROUGH A RE-INTERVENTION ON (B)(6) 2017 TO PREVENT THE POTENTIAL FOR PERMANENT IMPAIRMENT OF THE LEFT ARM. THE IMPLANTED CAGES WERE PLACED MEDIALLY ENOUGH TO RESULT IN THE PATIENT EXPERIENCING LEFT ARM NUMBNESS AND WEAKNESS FOR ABOUT 6 MONTHS BEFORE THE RE-INTERVENTION. ALL IMPLANTED CERVICAL CAGES FROM C4-C7 WERE REMOVED WITH LAMINOTOMY AND FORAMINOTOMY DURING PROCEDURE. BUT, THE PATIENT'S SYMPTOMS ARE STILL NOT TOTALLY RESOLVED.

  Patient problems: Numbness; Weakness

  MAUDE report 6790415 ↗
• MalfunctionAug 11, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A PATIENT WHO RECEIVED POSTERIOR C4-C7 CERVICAL INTERVERTEBRAL FUSION ON (B)(6) 2016 HAD TO GO THROUGH A RE-INTERVENTION ON (B)(6) 2017 TO PREVENT THE POTENTIAL FOR PERMANENT IMPAIRMENT OF THE LEFT ARM. THE IMPLANTED CAGES WERE PLACED MEDIALLY ENOUGH TO RESULT IN THE PATIENT EXPERIENCING LEFT ARM NUMBNESS AND WEAKNESS FOR ABOUT 6 MONTHS BEFORE THE RE-INTERVENTION. ALL IMPLANTED CERVICAL CAGES FROM C4-C7 WERE REMOVED WITH LAMINOTOMY AND FORAMINOTOMY DURING PROCEDURE. BUT, THE PATIENT'S SYMPTOMS ARE STILL NOT TOTALLY RESOLVED.

  Patient problems: Numbness; Weakness

  MAUDE report 6790411 ↗
• MalfunctionAug 11, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A PATIENT WHO RECEIVED POSTERIOR C4-C7 CERVICAL INTERVERTEBRAL FUSION ON (B)(6) 2016 HAD TO GO THROUGH A RE-INTERVENTION ON (B)(6) 2017 TO PREVENT THE POTENTIAL FOR PERMANENT IMPAIRMENT OF THE LEFT ARM. THE IMPLANTED CAGES WERE PLACED MEDIALLY ENOUGH TO RESULT IN THE PATIENT EXPERIENCING LEFT ARM NUMBNESS AND WEAKNESS FOR ABOUT 6 MONTHS BEFORE THE RE-INTERVENTION. ALL IMPLANTED CERVICAL CAGES FROM C4-C7 WERE REMOVED WITH LAMINOTOMY AND FORAMINOTOMY DURING PROCEDURE. BUT, THE PATIENT'S SYMPTOMS ARE STILL NOT TOTALLY RESOLVED.

  Patient problems: Numbness; Weakness

  MAUDE report 6790399 ↗
• MalfunctionDec 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SEVERE KYPHOSIS AND A C4-C7 ACDF IN (B)(6) 2015 PRIOR TO RECEIVING POSTERIOR CERVICAL FUSION. AFTER THE CERVICAL FUSION, THE PATIENT WOKE UP WITH NERVE PALSY AND WEAKNESS. THE PATIENT'S SYMPTOM WAS MONITORED BY THE SURGEON WHO HAD A CONCERN THAT THE COMBINATION OF NERVE PALSY AND WEAKNESS COULD BE DUE TO POSSIBLE PROXIMITY OF THE IMPLANT TO ARTERY NERVES AND FACET FRACTURE. THE SURGEON LATER CONFIRMED THAT THERE WAS NO INTERVENTION NECESSARY BECAUSE CT IMAGES SHOWED THE IMPLANT WAS NOT IMPINGING ON ANY NERVES. HOWEVER, THE CAUSE OF THE FACET FRACTURE WAS INCONCLUSIVE ACCORDING TO THE SURGEON. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS ALSO NO DEVICE DEFECT OR MALFUNCTION OF ANY TYPE REPORTED.

  Patient problems: Patient Problem/Medical Problem; Weakness

  MAUDE report 6179718 ↗
• MalfunctionDec 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SEVERE KYPHOSIS AND A C4-C7 ACDF IN (B)(6) 2015 PRIOR TO RECEIVING POSTERIOR CERVICAL FUSION. AFTER THE CERVICAL FUSION, THE PATIENT WOKE UP WITH NERVE PALSY AND WEAKNESS. THE PATIENT'S SYMPTOM WAS MONITORED BY THE SURGEON WHO HAD A CONCERN THAT THE COMBINATION OF NERVE PALSY AND WEAKNESS COULD BE DUE TO POSSIBLE PROXIMITY OF THE IMPLANT TO ARTERY NERVES AND FACET FRACTURE. THE SURGEON LATER CONFIRMED THAT THERE WAS NO INTERVENTION NECESSARY BECAUSE CT IMAGES SHOWED THE IMPLANT WAS NOT IMPINGING ON ANY NERVES. HOWEVER, THE CAUSE OF THE FACET FRACTURE WAS INCONCLUSIVE ACCORDING TO THE SURGEON. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS ALSO NO DEVICE DEFECT OR MALFUNCTION OF ANY TYPE REPORTED.

  Patient problems: Patient Problem/Medical Problem; Weakness

  MAUDE report 6179699 ↗
• MalfunctionDec 15, 2016Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  A PATIENT RECEIVED CERVICAL FUSION BUT DID NOT FOLLOW THE SURGEON'S POST-OPERATION ADVICE TO WEAR A SOFT COLLAR TO HELP STABILIZE THE SPINE DURING FUSION AND WAS ACTIVE IN GAMING WITHIN 14 DAYS OF THE SURGERY. THIS PATIENT LATER EXPERIENCED PAIN ON HIS RIGHT ARM. THE SURGEON BELIEVED THE GAMING ACTIVITY COULD HAVE LED TO AN IMPLANT MIGRATION RESULTED IN THE OBSERVED PAIN. THE SURGEON DECIDED TO PERFORM A REVISION SURGERY TO REMOVE AND REPLACE THE IMPLANT. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS ALSO NO REPORTED DEVICE MALFUNCTION BEFORE OR AFTER THE REVISION.

  Patient problems: Pain

  MAUDE report 6178292 ↗
• MalfunctionDec 7, 2016Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A SURGEON PERFORMED A CERVICAL FUSION FOR A PATIENT AND LATER DISCOVERED THROUGH POST-OPERATION X-RAY IMAGES THAT A CAGE WAS MALPOSITIONED INTO THE SOFT TISSUE AREA INSTEAD OF THE INTERVERTEBRAL JOINT AS INTENDED. THE SURGEON DECIDED TO PERFORM A POST-OPERATION REVISION TO REMOVE AND REPLACE THE MALPOSITIONED CAGE. THERE WAS NO DEATH OR SERIOUS INJURY OF ANY KIND REPORTED BEFORE OR AFTER THE REVISION SURGERY. THERE WAS ALSO NO DEVICE MALFUNCTION REPORTED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6153706 ↗
• MalfunctionNov 22, 2016Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  PATIENT RECEIVED A C5-C7 CERVICAL FUSION TO TREAT A PREVIOUSLY FAILED ACDF FUSION AT THE SAME LEVELS. PATIENT WOKE UP AFTER THE SURGERY WITH NUMBNESS AND PAIN IN THE RIGHT HAND AND THUMB. THE SURGEON TOOK A POST-OP CT SCAN AND DETERMINED THAT AN IMPLANT WAS PLACED TOO MEDIALLY WHICH COULD CONTRIBUTE TO THE PAIN. THE SURGEON DECIDED TO PERFORM A REVISION TO REMOVE THE CAGE AT C5-C6. THE PATIENT DID NOT REPORT ANY FURTHER OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS NO DEVICE MALFUNCTION IN THIS CASE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6123171 ↗
• MalfunctionNov 22, 2016Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A PATIENT RECEIVED A C3-C4 CERVICAL FUSION AND LATER EXPERIENCED SOME POST-SURGERY PAIN. THE SURGEON DISCOVERED THROUGH X-RAY IMAGES THAT ONE OF THE CAGES WAS POSITIONED LATERALLY INTO THE SOFT TISSUE AREA. THE SURGEON DECIDED TO PERFORM A REVISION TO REMOVE AND REPLACE THE MALPOSITIONED CAGE. THE PATIENT DID NOT REPORT ANY FURTHER OR WORSENING SYMPTOMS AFTER THE REVISION. THERE WAS NO DEVICE MALFUNCTION IN THIS CASE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6122887 ↗
• MalfunctionNov 9, 2016Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A PATIENT RECEIVED A POSTERIOR CERVICAL FUSION AND EXPERIENCED NEW RIGHT ARM PAIN AFTER SURGERY. THE SURGEON DISCOVERED THROUGH POST-OP CT SCAN EXAMINATION THAT THE CAGE AT C4-C5 WAS PLACED A LITTLE TOO ANTERIORLY. THE PATIENT WAS TAKEN BACK TO THE OR AND RECEIVED A REVISION TO REMOVE THAT CAGE AT C4-C5 WITHOUT REPLACEMENT. IT WAS REPORTED THAT THE PATIENT'S PAIN WAS RESOLVED WITHOUT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION. THERE WAS NO DEVICE MALFUNCTION REPORTED IN THIS CASE.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 6090147 ↗
• MalfunctionNov 9, 2016Malposition of Device; Patient-Device Incompatibility; Positioning Problem; Malposition of Device; Patient-Device Incompatibility; Positioning Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH CERVICAL CAGES FROM C4-T1 WENT THROUGH A REVISION ON (B)(6) 2016 DUE TO RIGHT ARM AND ULNAR PAIN. THE SURGEON DISCOVERED THROUGH POST-OP X-RAY EXAMINATION THAT THREE CAGES HAD SUBSIDED "LATERALLY" AND CAME OUT EASILY WHEN THE SURGEON USED A KOCHER INSTRUMENT TO REMOVE THEM DURING REVISION. THE SURGEON WHO PERFORMED THE REVISION HAD NOTED THAT THIS PATIENT HAS "LARGE FACETS". ALL CAGES FROM C4-T1 WERE REMOVED AND REPLACED WITH HOOK AND ROD FUSION. THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 6090143 ↗
• MalfunctionNov 9, 2016Malposition of Device; Patient-Device Incompatibility; Positioning Problem; Malposition of Device; Patient-Device Incompatibility; Positioning Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH CERVICAL CAGES FROM C4-T1 WENT THROUGH A REVISION ON (B)(6) 2016 DUE TO RIGHT ARM AND ULNAR PAIN. THE SURGEON DISCOVERED THROUGH POST-OP X-RAY EXAMINATION THAT THREE CAGES HAD SUBSIDED "LATERALLY" AND CAME OUT EASILY WHEN THE SURGEON USED A KOCHER INSTRUMENT TO REMOVE THEM DURING REVISION. THE SURGEON WHO PERFORMED THE REVISION HAD NOTED THAT THIS PATIENT HAS "LARGE FACETS". ALL CAGES FROM C4-T1 WERE REMOVED AND REPLACED WITH HOOK AND ROD FUSION. THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT DID NOT REPORT ANY NEW OR WORSENING SYMPTOMS AFTER REVISION.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 6090128 ↗
• MalfunctionOct 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON PERFORMED A CERVICAL FUSION AT C4-C7 ON (B)(6) 2016 USING CERVICAL CAGES. FOLLOWING THE INITIAL SURGERY, THE PATIENT'S SYMPTOMS WERE NOT RESOLVED. THE PATIENT CONSULTED A SECOND SURGEON FOR ANOTHER OPINION. UPON EXAMINATION AND IMAGING STUDIES, THE SECOND SURGEON DETERMINED CAGE PLACEMENT AT C4-C5 WAS TOO MEDIAL AND POTENTIALLY CAUSING NERVE IRRITATION. ON (B)(6) 2016, THE SECOND SURGEON REVISED THE ORIGINAL CERVICAL FUSION BY REMOVING THE INITIALLY PLACED CERVICAL CAGES AND IMPLANTING LATERAL MASS SCREWS AND RODS FROM C4-C7. THE REVISION SURGERY WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: Pain

  MAUDE report 6012716 ↗